Configuration & QC Spec I

Job Title: Configuration & QC Specialist I

Location: Leopardstown, Dubbin 18

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for a Configuration & QC Specialist I to join the team in our Leopardstown, Dublin 18 location.

The Role:

To support the Project Management Team (PM) in configuring and QC'ing new studies in all ICL systems according to the specifications on the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables, and study specific Lab Manuals.

• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Work closely with the PM team in interpreting the CLW specs and ensuring that all is clear and accurate enough for proper configuration into all systems, seeking guidance on any parameters that need clarification.*
• Provide PM with configuration support by entering selected elements of the study's specifications into ICL systems (e.g. PACS, LIMS, and ICOLIMS).*
• Create supporting documents for sites that facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables, study-specific Lab Manuals, and collection guides.*
• Support PM in the creation of all configuration-related forms, such as Value Calculation Forms and the LIS Forms.*
• Assist PM in preparing pdf documents for links to ICOLIMS and Read Only drive posting.
• When updates or additions are required for collection, packaging, shipping instructions or contact information to a study-specific Lab Manual or Requisitions, work with CS Leadership to determine whether or not those updates are warranted in the Lab Manual or Requisition Template and make those updates accordingly.
• Perform new study configuration quality checks on all databases, internal forms and supporting documents to ensure high quality output and adherence to the CLW specs.*
• Perform level-appropriate quality checks on database and document updates for all amendments performed by PM.
• Verify and post documents for Read Only access once finalized, checking for adherence to version history and version control procedures.
• Performs additional relevant responsibilities as requested by management

• Provide technical support and guidance to PM for all study configuration tasks

What you will need:

• Bachelor's Degree or equivalent combination of experience and education
• One year of related experience in Clinical Trials, Laboratory, or similar database configuration work
• Knowledge of basic computer programs
• Excellent written communication skills
• Ability to manage multiple projects and exhibit appropriate time management skills
• Experienced multi-tasker
• An understanding of client and site needs is a plus
• Self-starter with track record of well-developed learning strategies
• Must be self-motivated and work well with various internal groups